LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER

K050168 · Vascular Solutions, Inc. · DQO · May 18, 2005 · Cardiovascular

Device Facts

• Record ID: K050168
• Device Name: LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER
• Applicant: Vascular Solutions, Inc.
• Product Code: DQO · Cardiovascular
• Decision Date: May 18, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The Vascular Solutions Langston™ Dual Lumen Pigtail Catheter is indicated for delivery of contrast media in angiographic studies and for simultaneous pressure measurement from two sites. This type of pressure measurement is useful in determining transvalvular, intravascular and intraventricular pressure gradients.

Device Story

Langston™ Dual Lumen Pressure Monitoring Catheter facilitates simultaneous pressure measurement and contrast media delivery during angiographic procedures. Device comprises inner lumen (Merit Medical Softouch Diagnostic Intravascular Catheter) and extruded outer lumen joined by adapter junction. Distal end of outer lumen features holes for pressure sensing; inner lumen accommodates standard 0.038'' guidewires. Used by physicians in clinical settings (e.g., cath lab) to assess pressure gradients across valves or within vessels/ventricles. Output is real-time pressure data displayed on external monitoring equipment, enabling clinical decision-making regarding hemodynamic status and valvular function.

Clinical Evidence

No clinical data. Bench testing only, including design verification and biocompatibility assessments.

Technological Characteristics

Dual lumen catheter; inner lumen (Merit Medical Softouch); extruded outer lumen; adapter junction with side port/stopcock; 0.038'' guidewire compatibility; distal holes for pressure sensing.

Indications for Use

Indicated for patients undergoing angiographic studies requiring contrast media delivery and simultaneous pressure measurement at two sites to determine transvalvular, intravascular, and intraventricular pressure gradients.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Predicate Devices

• Dual Lumen Pigtail Catheter
• Cordis Dual Lumen Pressure Monitoring Catheter
• Merit Medical Softouch Diagnostic Intravascular Catheter (K943739)

Submission Summary (Full Text)

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K050168

MAY 1 8 2005

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

| Common/Usual Name: | Intravascular Diagnostic Catheter |
|-----------------------------|---------------------------------------------------------------------------------------------------|
| Product Trade Name: | Langston™ Dual Lumen Pressure Monitoring Catheter |
| Classification Name: | Class II<br>21 CFR 870.1200<br>Product Code: DQO |
| Manufacturer: | Vascular Solutions, Inc.<br>6464 Sycamore Court<br>Minneapolis, Minnesota 55369<br>USA |
| Establishment Registration: | 2134812 |
| Contact: | Sara L. Coon<br>Senior Regulatory Affairs Associate<br>[phone] phone<br>[phone] fax |
| Performance Standards: | No performance standards have been developed under<br>section 514 for this device. |

## Device Description:

Device Desemplosi.
The Vascular Solutions Langston™ Dual Lumen Pressure Monitoring catheter is intended for use as a pressure measurement catheter and for delivery of contrast media during angiographic studies. The DLP catheter consists of the Merit Medical Softouch Diagnostic Intravascular Catherer (K943739) as the inner lumen and an extruded outer lumen designed by Vascular Solutions. The inner lumen and hub assembly are purchased from Merit Medical in a non-sterile state. The Merit Softouch catheter and outer lumen are joined together using an adapter junction placed near the proximal end of the Merit Softouch catherer. The adapter junction incorporates a side port fitted with a stopcock/tube assembly for fluid flow and pressure measurement within the outer tube. The distal end of the outer for trail 110 ware possible holes to allow pressure measurement simultaneously with the tube is personed was as a catheter. The dual lumen catheter is deployed through standard sidences at are and will accommodate standard 0.038'' diameter guidewires.

### Intended Use:

The Vascular Solutions Langston™ Dual Lumen Pigtail Catheter is indicated for delivery of The vacouxi oor in angiographic studies and for simultaneous pressure measurement from two sites. This type of pressure measurement is useful in determining transvalvular, intravascular and intraventricular pressure gradients.

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## Summary of Non-Clinical Testing:

Sunnillary of Non-Gillicar 2 council.
Testing conducted included assessments of the design verification of the Dual Lumen I esuits conducted mended assessments biocompatibility assessments. The results of this Fressure Monitoning Catherer assist ""
battery of tests confirmed the suitability of the Dual Lumen Pressure Monitoring Catheter for its intended use.

## Summary of Clinical Testing:

No clinical evaluations of this product have been conducted.

#### Predicate Device

I Iculcate Device I The Dual Lumen Pigtail Catheter, the Cordis Dual Lumen Pressure Monitoring Catheter, and the Merit Medical Softouch Diagnostic Intravascular Catheter.

## Conclusions:

The Langston Dual Lumen Pressure Monitoring Catheter is substantially equivalent to the I The Langston Dual Lumen Pigtail Catheter , the Cordis Dual Lumen Pressure Monitoring Latheter and the Merit Medical Softouch Diagnostic Intravascular Catheter. The testing Catheter and the Heather the Langston Dual Lumen Pressure Monitoring Catheter will perform as intended.

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Image /page/2/Picture/1 description: The image is a black and white emblem for the U.S. Department of Health & Human Services. The emblem features the department's logo, which consists of three stylized human figures connected by flowing lines, representing the department's mission to protect the health of all Americans. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 1 8 2005

Ms. Sara L. Coon Senior Regulatory Affairs Associate Vascular Solutions, Inc. 6464 Sycamore Court Minepolis, MN 55369

Re: K050168

Trade/Device Name: Langston™ Dual Lumen Pressure Monitoring Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: II Product Code: DQO Dated: May 3, 2005 Received: May 4, 2005

Dear Ms. Coon:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nevers for was your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass surfed to May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered prox conner 2012/ 2018 11:12 provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, therefered, issions of the Act include requirements for annual registration, listing of general concess profile to proctice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 -- Ms. Sara L. Coon

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 100-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050 product radiation control provisions (Sections 991 ceries in your Section 510(k)
This letter will allow you to begin marketing your device of your daying to Jeggl This letter will allow you to begin makemig your avvalence of your device to a legally premarket notification. The PDA intallight substanced by and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please e If you desire specific advice for your aconce to and one one the regulation entitled, the regulation entitled, comact the Office of Comphalloo at (210) 276 off (21CFR Part 807.97). You may obtain "Misbranding by reference to premarket to premailities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or 1 Manufacturers, International and Consalher physical on the many of the new learners himl.

Sincerely yours,

Bhimman for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number:

K050168

Device Name:

Vascular Solutions Langston™ Dual Lumen Pressure Monitoring Catheter

Indications for Use:

The Vascular Solutions Langston™ Dual Lumen Pressure Monitoring Catheter is indicated for The Vascular Solutions Earingershic studies and for simultaneous pressure measurement ticavely of containt modeline in angest of the good intravascular and intraventricular pressure gradients.

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bhimman

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K050168

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